Hospital

Hospital means a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (such as medical, occupational, speech, physical), surgical, and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, rehabilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (e.g., not a part of a provider of services or any other facility) or may be operated by another medical entity (e.g., under the common ownership, licensure, or control of another entity). A hospital is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital.

Source

21 CFR § 803.3

---

Scoping language

Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute . Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:

---

Is this correct? or